Details for New Drug Application (NDA): 210854
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The generic ingredient in XOFLUZA is baloxavir marboxil. One supplier is listed for this compound. Additional details are available on the baloxavir marboxil profile page.
Summary for 210854
Tradename: | XOFLUZA |
Applicant: | Genentech Inc |
Ingredient: | baloxavir marboxil |
Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210854
Generic Entry Date for 210854*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 210854
Mechanism of Action | Chelating Activity Polymerase Acidic Endonuclease Inhibitors |
Suppliers and Packaging for NDA: 210854
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854 | NDA | Genentech, Inc. | 50242-860 | 50242-860-01 | 1 BLISTER PACK in 1 CARTON (50242-860-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854 | NDA | Genentech, Inc. | 50242-860 | 50242-860-86 | 1 BLISTER PACK in 1 CARTON (50242-860-86) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 24, 2018 | TE: | RLD: | Yes | |||||
Patent: | 10,392,406 | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | 10,633,397 | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA | ||||||||
Patent: | 10,633,397 | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD FOR TREATING INFLUENZA |
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